Regulatory requirements are becoming more complex for manufacturers and providers of medical products, devices, components and services. So how can you bring new and improved medical products to the market quickly, while meeting the highest quality standards and all relevant global regulations?

Why choose food and drug administration (FDA) foundation training from SGS?

We can help you:

Understand the underlying philosophy, principles, concepts and requirements of the FDA QSR CFR 820 regulations

The Trusted Food and Drug Administration (FDA) Foundation Course From SGS From Singapore’s Leading ISO Certification Training Provider

As a leading ISO certification training provider, we offer unrivaled expertise in food and drug administration (FDA) foundation training. Our one-day course is designed to cover the following key topics:

Introduction to FDA QSR 21 CFR § 820
- Perception of FDA
- Food, Drug and Cosmetic Act (FD&C Act)
- Regulatory Classes

FDA QSR 21 CFR 820 regulations overview (subpart A to O):
- Subpart A – General provision
- Subpart B – Quality system requirement
- Subpart C – Design controls
- Subpart D – Document controls
- Subpart E – Purchasing controls
- Subpart F – Identification and traceability
- Subpart G – Production and process controls
- Subpart H – Acceptance activities
- Subpart I – Non-conforming product
- Subpart J – Corrective and preventive actions
- Subpart K – Labeling and packaging
- Subpart L – Handling, storage, distribution and installation
- Subpart M – Records
- Subpart N – Servicing
- Subpart O – Statistical techniques